At a glance
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Effect of Acupuncture Pre-treatment Combined With Letrozole on Live Birth in Infertile Women With Polycystic Ovary Syndrome
In Brief
A Phase 3 clinical trial evaluating Pre-treatment acupuncture and Letrozole for Polycystic Ovary Syndrome. Completed, enrolled 384 participants across 1 site.
Detailed Summary
This is a study protocol for a multicenter, randomized, and controlled trial. In this protocol, we present a randomized controlled trial comparing acupuncture pretreatment followed by letrozole vs letrozole alone in polycystic ovary syndrome (PCOS) women with anovulatory infertility. The high prevalence of insulin resistance (IR) in women with PCOS women is considered to be one of the major pathophysiological changes of PCOS, leading to anovulatiory infertility. A study has shown that electro-acupuncture could significantly improve insulin sensitivity. The effect of acupuncture pretreatment on anovulatory PCOS women followed by ovulation induction has not been investigated before. A total of 384 patients enrolled in this study will be randomized into one of two groups. The treatment group: a 16 week acupuncture pretreatment followed by 4 cycles of letrozole and the control group: 4 cycles of letrozole alone. The primary outcome is the live birth rate. We postulate that acupuncture pretreatment followed by letrozole results in a higher live birth rate when compared with letrozole alone.
Study Details
Timeline
Interventions
Acupuncture treatment will start on day 3-5 after a spontaneous period or after a withdrawal bleeding following progestin. They will receive acupuncture treatment three times a week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 16 weeks.
Starting from 2.5mg daily from day 3-5 for 5 days after a spontaneous period or after a withdrawal bleeding following progestin, one time per day.Participants are treated for up to 4 cycles.